MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO; CATHETER, CORONARY, ATHERECTOMY

Model Number 39467-175

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2024

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter address 1: (b)(6).

Event Description

It was reported that the wire was not locking.A 1.75mm rotapro was used together with a rotawire.During insertion, it was noted that the rotawire was not locking with the advancer.The rotawire could not be locked even during dynaglide mode, and the button for unlocking was not in use.The device was able to be removed while in normal mode and the procedure was completed with another of the same device.There was no patient injury reported.

Manufacturer Narrative

E1.Initial reporter address 1: (b)(6).D4.Lot number, expiration date and h4.Device manufacture date corrected.Device evaluated by manufacturer: the device was returned for analysis.The burr catheter was received attached to the advancer unit.The advancer, handshake connections, sheath, coil, burr and annulus were visually examined.Inspection of the device found no damages or defects.The rotawire used in the procedure was not returned; a test wire was used for analysis.The rotawire was inserted into the annulus of the burr and advanced the through the advancer with no resistance or issues.Functional testing was then performed by connecting the advancer to the rotapro control console.During functional testing, the brake engaged when the ablation button [knob switch] was pressed and held the wire in place in both normal and dynaglide mode with no resistance or issues.Product analysis did not confirm the reported event, as the test wire was not able to move when the ablation button was pressed.

Event Description

It was reported that the wire was not locking.A 1.75mm rotapro was used together with a rotawire.During insertion, it was noted that the rotawire was not locking with the advancer.The rotawire could not be locked even during dynaglide mode, and the button for unlocking was not in use.The device was able to be removed while in normal mode and the procedure was completed with another of the same device.There was no patient injury reported.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC LTD; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18734431
• MDR Text Key: 336743092
• Report Number: 2124215-2024-09523
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 39467-175
• Device Catalogue Number: 39467-175
• Device Lot Number: 0032497236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/19/2024
• Supplement Dates Manufacturer Received: 03/03/2024
• Supplement Dates FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1